The Infrared Non-Contact Thermometers, ACT8100, is non-sterile, reusable clinical thermometers intended for the intermittent determination of human body temperature measured at the center of the forehead without contact. The device is intended for use on people of all ages, except pre-term babies or very small (small for gestational age). The device is intended for use in clinical and home use environments.

Device Description

The Infrared Non-Contact Thermometer, ACT8100 is a hand-held device powered by batteries and designed to measure human body temperature without contacting patients. This thermometer can switch modes between forehead and ambient temperatures. The ambient temperature mode is DIRECT MODE and the forehead temperature mode is ADJUSTED MODE. The forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an oral equivalent temperature without contacting the patient's forehead. Infrared Non-Contact Thermometer, ACT8100 uses a thermopile integrated with a thermistor, a thermistor mounted on the head of the thermometer for ambient temperature readings, and an optoelectronic mechanism that focuses the infrared energy emitted from the user s forehead for the detection of noncontact use and calibration of temperature reading.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Infrared Non-Contact Thermometer, Model ACT8100, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard & Requirement)	Reported Device Performance (ACT8100)
Laboratory Accuracy (ASTM E1965-98:2009 & ISO 80601-2-56:2009)
35.0 °C ~ 42.0 °C	± 0.2 °C (for 35.0~42.0°C)
Below 34.9 °C or Above 42.1 °C	± 0.3 °C (for below 34.9°C or above 42.1°C)
Repeatability (EN12470-5:2003, subclause 6.3.4)	Under 0.3℃
Measuring Range	32.0 °C ~ 43.9 °C (89.6 °F ~ 111.0 °F)

Note: The document states that the ACT8100's accuracy and measuring range "All meet ASTM E 1965-98:2009". The specific criteria for ASTM E1965-98:2009 for the full range are a bit more detailed, but the provided table summarizes the reported performance against the specified ranges.

2. Sample Size Used for the Test Set and Data Provenance

The document states:

"The three groups of subjects being tested were: (1) Infants of under 1 year old, (2) Children between 1 to 5 years old, (3) Adults"
However, the specific number of subjects (sample size) within each group or the total sample size for the clinical study is not provided.
Data Provenance: The country of origin for the data is not explicitly stated in the provided text. The submission is from TAIWAN (Easywell Biomedicals, Inc.), so it's likely the study was conducted there, but this is not confirmed. The study was prospective in nature, as it involved taking measurements from subjects using the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used to establish the ground truth or their qualifications.
The ground truth was established by a "reference thermometer, Actherm Digital Clinical Thermometer ACT 2130 (K031905), either at the rectal, oral, or axillary site depending on their age group." While this is a reference device, it doesn't involve "experts" in the sense of human readers adjudicating images; rather, it's a direct measurement.

4. Adjudication Method for the Test Set

An adjudication method (like 2+1, 3+1) is not applicable here as the ground truth was established by direct temperature measurements from a reference thermometer, not by human interpretation that requires consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with AI vs. without AI assistance. This device is a standalone non-contact thermometer, not an AI-assisted diagnostic tool that humans would interpret.
The study did compare the ACT8100's measurements to a predicate device (NTF 3000) and a reference standard (ACT 2130), demonstrating similar clinical biases and repeatability, but this is not an MRMC study.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance study was done. The entire clinical evaluation detailed in Section X ("Clinical Testing") is a standalone performance assessment of the ACT8100. It directly measures the device's accuracy and repeatability against a reference standard and compares it to a predicate device without human interpretation of the device's output.

7. Type of Ground Truth Used

The type of ground truth used was measurements from a reference standard device, specifically the "Actherm Digital Clinical Thermometer ACT 2130 (K031905), either at the rectal, oral, or axillary site depending on their age group." This is clinical measurement-based ground truth.

8. Sample Size for the Training Set

The document does not provide information on a "training set" or its sample size. This type of non-AI, hardware-based medical device typically does not involve machine learning training sets in the same way an AI-powered diagnostic algorithm would. The device's calibration and algorithm for converting infrared readings to oral equivalent temperatures would have been developed during its R&D phase, but a distinct "training set sample size" with associated ground truth for a retrospective ML model is not applicable here.

9. How the Ground Truth for the Training Set Was Established

As there's no mention of a distinct "training set" in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided information. The device's internal algorithms would have been developed and validated through engineering and laboratory testing, likely using controlled temperature sources and potentially clinical data, but not typically referred to as a "training set" in this context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2017

Easywell Biomedicals, Inc. Arthur Chen Quality Assurance Manager Suite 2, 2F, No.9, Jhanye 1st Rd, Hsinchu Science Park Hsinchu, 30078 TAIWAN

Re: K162509

Trade/Device Name: Infrared Non-contact Thermometer, Model ACT8100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 26, 2017 Received: February 15, 2017

Dear Arthur Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162509

Device Name

Infrared Non-Contact Thermometer, Model ACT8100

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K162509 510(k) Summary

I. Submitter

EASYWELL BIOMEDICALS, INC.

Suite 2, 2F, No.9, Jhanye 1st Rd., Hsinchu Science Park, 30078 Hsinchu, TAIWAN

Phone:+886-3-666-9596

FAX: +886-3-666-9697

Contact Person:Richard Hsieh

Date: January 25, 2017

II. Device

Trade Name:Infrared Non-Contact Thermometer, Model ACT8100

Common Name: Infrared Thermometer

Regulation Number: 21 CFR 880. 2910

Regulation Name:Clinical Electronic Thermometer

Regulatory Class : II

Product Code:FLL

III. Predicate Device

K134043 : BRAUN No Touch + Forehead Thermometer; ModelNTF3000US (US Model)

Reference Device

K031905: Actherm Digital Clinical Thermometer ACT 2130

IV. Device Description

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Physical and Performance characteristics:

Dimension	163×44×26mm approximately
Weight	Approximately 75g without battery; 88g with batteries
MeasuringRange	32.0 °C ~ 43.9 °C (89.6 °F ~ 111.0 °F)
Accuracy	± 0.2 °C (for 35.0~42.0°C); ± 0.3°C (for below 34.9°C or above42.1°C)

V. Indication for Use

VI. Conformance Standards

The Infrared Non-Contact Thermometers conform to the following standards:

1. ISO 80601-2-56:2009 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
1. ASTM E1965-98:2009 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
1. IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
1. IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard Electromagnetic compatibility -Requirements and tests
1. IEC 60601-1-11:2010 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
1. ISO 14971:2007 Medical Devices: Application of Risk Management to Medical Devices.
1. Software: FDA Guidance for the Content of Premarket Submissions for Software contained in Medical Device
1. ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
1. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
1. ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for irritation and delayedtype hypersensitivity

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	VII. Similarities/Differences between the subject and predicate device:

	Subject Device(s)	Predicate Device
ELEMENT OFCOMPARISON	ACT8100	No touch + foreheadthermometer(NTF3000US)	Comparison
Classification	ThermometerClinical Electronic,Class II Device	ThermometerClinical Electronic,Class II Device	The deviceclassifications areidentical
Intended Use	A non-sterile, reusableclinical thermometerintended for theintermittentdetermination of humanbody temperaturemeasured at the centerof the forehead withoutcontact. The device isintended for use onpeople of all ages,except pre-term babiesor very small (small forgestational age). Thedevice is intended foruse in clinical and home	A non-sterile, reusableclinical thermometerintended for theintermittentdetermination of thehuman's bodytemperature in a touchand no touch on thecenter of the foreheadas the measurement siteon people of all ages.	The intended usestatements aresimilar
Sensor	Infrared: converts auser's foreheadtemperature using theinfrared energy emittedin the area around theuser's forehead to anoral equivalenttemperature whenplaced up to 2-8cmaway.	Infrared: converts auser'sforeheadtemperature using theinfrared energy emittedin the area around theuser's forehead to anoral equivalenttemperature whenplaced in contact withthe subject's foreheador up to 2 inches away.	Technologicalcharacteristics aresimilar
ELEMENT OFCOMPARISON	Subject Device(s)	Predicate Device	Comparison
PowerRequirement	ACT8100:1.5V AAA size Alkaline battery *2	1.5V AA size battery *2	Battery size different, but the power requirements are similar (voltage outputs are the same)
	Dimensions:163×44×26 mm	Dimensions:Length:148Head: 44×26 mmBody: 37×24 mm	Head dimension is similar, the body length is different.
Functionality	Materials:All skin contacting materials have been tested in accordance with ISO 10993-1、-5、-10.	Materials:All skin contacting materials have been tested in accordance with ISO 10993-1、-5、-10.	Material characteristics all meet biological requirements
	Measuring ranges:$32.0 °C ~ 43.9 °C$	Measuring ranges:$34.4 °C ~ 42.2 °C$	All meet ASTM E 1965-98:2009
	Accuracy:$35.0 °C ~ 42.0 °C: ± 0.2 °C$$<35.0 °C$ or $>42.0 °C: ± 0.3 °C$	Accuracy:$35.0 °C ~ 42.0 °C: ± 0.2 °C$Out of above range: ± 0.3 °C	All meet ASTM E 1965-98:2009
	Forehead measuring distance:2~8 cm	Forehead measuring distance:0~5 cm	Similar

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VIII. Comparison of Technological Characteristics with the Predicate Device:

The technological characteristics of ACT8100 and predicate device (NTF3000US) are similar. Both convert user's forehead temperature using the infrared energy emitted in the area around the user 's forehead to an oral equivalent temperature.

The differences between ACT 8100 and predicate device (NTF3000US) do not raise different questions of safety or effectiveness.

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Difference	Difference Description	Reasons why not raising new questions
Battery size	ACT 8100 using AAA size,the predicated device(NTF3000US) using AA size	The output voltage is the same, and thedifferences are verified not to raise newquestions regarding safety and effectivenessrequirements within standard IEC60601-1electrical safety requirements and IEC 60601-1-2 EMC test.
Dimensions	The design of shape is notvery similar.	The differences are verified not to raise newquestions regarding safety and effectivenessrequirements within standard IEC60601-1electrical safety requirements & ASTM E1965-98:2009
Ambientmeasuringranges	ACT 8100 (32.0°C ~ 43.9°C)is a little wider than The NoTouch + ForeheadThermometer (34.4°C ~42.2°C).	The differences are verified not to raise newquestions regarding safety and effectivenessrequirements within standard IEC60601-1electrical safety requirements & ASTM E1965-98:2009
Foreheadmeasuringdistance(sensor)	The predicated device(NTF3000US) designed forboth contact and no-contact.ACT 8100 is designed foronly non-contact.	The differences are verified not to raise newquestions regarding safety and effectivenessrequirements within standard IEC60601-1electrical safety requirements & ASTM E1965-98:2009

IX. Non-Clinical Safety and Performance Testing

Non-clinical performance tests used to demonstrate the substantial equivalence of ACT 8100 to the predicate device. The device conforms to the requirements of laboratory accuracy, general electrical safety, electromagnetic compatibility and biocompatibility. Thus, the device has the same performance characteristics as the predicate device.

Non-Clinical PerformanceTesting	Standard/Guidance Applied and Conformed
Laboratory accuracy	ASTM E1965-98:2009ISO 80601-2-56:2009
General Electrical Safety	IEC 60601-1:2012IEC 60601-1-11:2010
ElectromagneticCompatibility	IEC 60601-1-2:2014
Biocompatibility	ISO 10993-1;ISO 10993-5; ISO 10993-10
Software	IEC 62304
Usability	IEC 62366
Risk Management	ISO 14971

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X. Clinical Testing

A clinical study was performed to determine the clinical accuracy and to provide comparison with the predicate device. The three groups of subjects being tested were: (1) Infants of under 1 year old, (2) Children between 1 to 5 years old, (3) Adults

Each group of subjects underwent a series of temperature measurement at their forehead and back of ear using ACT 8100 and BRUAN Infrared no touch + forehead thermometer NTF 3000. This series of measurement was intended to indicate and ultimately compare the repeatability of ACT 8100 and NTF 3000. The repeatability of both devices is found to be under 0.3℃. which is within the acceptable range as required by EN12470-5:2003, subclause 6.3.4. In addition, the repeatability of the both devices were found to be similar, further indicating that the ACT 8100 has reasonable accuracy and reliability. The three subject groups underwent a series of temperature measurement using the reference thermometer, Actherm Digital Clinical Thermometer ACT 2130 (K031905), either at the rectal, oral, or axillary site depending on their age group. These temperature measurements were then each compared to the temperature measurements taken by ACT 8100 and that of NTF 3000. The clinical biases of these measurements taken by ACT 8100 were found to be similar to that of NTF 3000, indicating that ACT 8100 produces effective and accurate temperature measurements.

XI. Conclusion

Infrared Non-Contact Thermometers, ACT8100 has similar intended use, principles of operation, and similar technological characteristics as the predicate device identified. Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. Results from the clinical study demonstrate substantial equivalence of accuracy and reliability of ACT 8100 and its similarity with NTF 3000. Thus, the Infrared Non-Contact Thermometer is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.